Supplements in Peril Update

FDA must be worried—they’ve extended the comment period for the supplement guidance. We must use the opportunity to flood the agency with more comments. Please help out! Highest-Level Action Alert!
This past August, the FDA issued its long delayed guidance detailing how the supplement industry can bring new products to the market. The guidance deals with how and whether the supplement industry is allowed to innovate and create new supplements, also called “new dietary ingredients” (NDIs for short).
There are many, many problems with this guidance that you can read more about in our original coverage, but the main point is simple: if this current guidance becomes final with no modifications, consumers will very likely lose access to thousands of supplements. In some cases, ingredients that have been available as supplements could be handed over to the pharmaceutical industry. Innovation will be quashed.
We believe this is exactly what the FDA and its Big Pharma allies want. Only the American public can stop it.
Over the last few months, ANH-USA members and other stakeholders have inundated the FDA with comments—addressing the substance of the guidance as well as asking the FDA to extend the comment period to give the public ample time to respond.
The FDA paid attention because the only thing it fears is Congress—and the only thing Congress fears is the voters. The agency responded and agreed to extend the comment period on the guidance sixty days, to December 12, 2016.
We cannot stress how critical it is for everyone who has not yet submitted a comment to the FDA on this issue to do so now. The guidance will threaten too many vital supplements and effectively kill innovation in the supplement industry. We must stop the FDA from moving forward with its new regulations disguised as a “guidance” document.Highest-Level Action Alert! If you haven’t already, send a message to the FDA detailing all of the problems with their NDI guidance document. Please send your message immediately!

3 responses to “Supplements in Peril Update”

Folks, this is an opportunity to guide the politicians who are up for re-election. The fact is that in our representative democracy the influence-makers for these politicians are the lobbyists (read “salespersons”) for the chemical-drug manufacturer-distributor businesses. These businesses provide money to re-election campaigns, directly or indirectly, and thus steer the politicians toward supporting whatever the businesses are wanting in return. What they want is to maximize their profit to satisfy their corporate investors. This has nothing to do with ethics, truth, health, public fiscal integrity and responsibility, or scientific evidence regarding either drugs or supplements. Their interest is strictly their bottom line: profit and power-to-influence the politician.
The rare exception is when the politician is looking for votes, as in this election cycle. To insist that the politician “do the right thing” and deny the lobbyists and their employers carte blanche in deciding what people have access to in this country — that is, allowing them the ability to deny vitamins and herbs through governmental agencies such as the FDA — is the basic right and duty of citizens.
The FDA itself is essentially autonomous — except for its reliance on the congress for partial funding and for writing the laws the FDA wants enacted, which over the decades provided the agency increasing power to control the vitamin and supplement marketplace — and is beholden to the chemical-drug manufacturer-distributor businesses for the majority of its funding. This vested interest is essentially the “fox guarding the chicken house” and has been described by a former FDA director who stated that what the public believes the FDA does and what it actually does is vastly different. What the FDA does is take enormous sums of money from the drug manufacturers to “oversee” the required “studies” (the results of which are usually either “made-up” in an office by drug-company personnel or a comparison of drug A versus drug B on the symptoms of a disease or condition, and having nothing to do with health or curing the disease) in order to grant “approval” to market the drug. FDA directors have been known to overrule their own medical and scientific review boards who sometimes warn of the dangers of approving a drug. Upper level FDA managers are commonly recruited by the very drug business they are supposed to be regulating, and drug company executives are commonly appointed to upper management positions within the FDA. This revolving door explains some of the poor decisions made by the FDA (such as allowing Vioxx to continue its marketing even when upwards of seventy-thousand people had died using the drug).
The chemical-drug manufacturer-distributor businesses generally do not want competition from vitamin and herbal supplements. One valuable vitamin B form known as “pyridoxamine” was removed from the market by the FDA at the request of a drug company which didn’t want to compete with it and therefore “patented” the vitamin. Once the FDA classified the vitamin as a “drug” then retired the vitamin. Currently, the FDA is looking at removing an extract of the periwinkle plant (vinpocetine) and another form of vitamin B.
Which brings us to the current petition in answer to the FDA’s call for responses to its proposal to essentially place vitamins, herbs and other supplements in the “drug” category so that (thanks to the politician-supported regulations allowing this inanity) the FDA can control them (that is, remove them from the public marketplace, make them extremely expensive if a drug company decides to sell them, or allow them to be “shelved” forever). To call a “horse” a “dog” does not make the horse bark.
Take a few minutes to think about what you want for your future. Do you want your children and future generations to have no access to vitamins and herbs? Do you want to give up your freedom to choose which vitamins or herbs you take? Do you want to allow the chemical-drug manufacturer-distributor businesses to increase their monopolistic control over the “sick-care” business to the benefit of their stockholders and to the detriment of most of the rest of us? Do you want the FDA managers to further consolidate their out-of-control hold on our remaining choices regarding our own bodies and what we put in them (as long as they are “generally recognized as safe” and/or have been used for hundreds or thousands of years without problems)?
Tell the politicians what you want them to do. They work for you. The FDA works for you. Do not let the wealthy, the powerful and the corrupt usurp the freedoms we still enjoy.
It’s your life. It’s your decision. Make it a positive one.

The link in the article re: “our original coverage” is not working. I would really like to read it so I can have some more background into what’s going on here. I would like to educate myself so I can make an informed comment and possibly contact my Congressional Rep and Senators. Thank you.

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